ONE PC MLD,10LD,MAC2000,BANANA,8',AHA 28079

GUDID 00840828187053

ONE PC MLD,10LD,MAC2000,BANANA,8',AHA

CURBELL MEDICAL PRODUCTS, INC.

Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable Electrocardiographic lead set, reusable
Primary Device ID00840828187053
NIH Device Record Key7171e4fa-4056-46df-8cd1-0da5de86e2c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameONE PC MLD,10LD,MAC2000,BANANA,8',AHA
Version Model NumberMCB-10DC-08AS-0042
Catalog Number28079
Company DUNS796452311
Company NameCURBELL MEDICAL PRODUCTS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com
Phone1-800-235-7500
Emailmwinter@curbell.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100840828187053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DSACable, Transducer And Electrode, Patient, (Including Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-08
Device Publish Date2022-11-30